Generic drug of Arimidex
Therapeutic class: Oncology and hematology
active ingredients: Anastrozole
laboratory: Teva Sante
Box of 90
All forms
Indication
ANASTROZOLE TEVA is indicated for the treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Dosage ANASTROZOLE TEVA 1 mg Film-coated tablet Box of 90
Dosage
The recommended dose of ANASTROZOLE TEVA in adults, including the elderly, is one tablet at 1 mg once daily.
Special populations
Pediatric population
ANASTROZOLE TEVA is not recommended for use in children and adolescents because of insufficient safety data and efficacy (see Warnings and Precautions and Pharmacodynamic Properties sections).
Renal failure
No dosage modification is recommended for patients with mild or moderate renal impairment. In patients with severe renal impairment, ANASTROZOLE TEVA should be administered with caution (see sections Warnings and Precautions and Pharmacokinetic Properties ).
Hepatic insufficiency
No dosage modification is recommended for patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment (see Warnings and Precautions ).
Administration mode
ANASTROZOLE TEVA should be taken orally.
Against indications
A nastrozole TEVA is contraindicated in:
· Pregnant or lactating women.
Patients with known hypersensitivity to anastrozole or to any of the excipients listed in the Composition section.
Adverse effects Anastrozole Teva
The following table presents adverse effects from clinical studies, post-marketing studies, or spontaneous reports. Unless specified, frequency groups were calculated from the number of adverse events reported in a large phase III study in 9, 366 postmenopausal women with operable breast cancer who received adjuvant therapy for 5 years (study ATAC: Anastrozole, Tamoxifen, Alone or in combination study).
The side effects listed below are classified by frequency and system organ class (SOC). Frequency groups are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), and very rare (<1/10 000). The most common side effects were headache, hot flush, nausea, rash, arthralgia, joint stiffness, arthritis and asthenia.
Table 1. Adverse reactions by system organ class and frequency
Side effects by SOC and frequency | ||
Metabolism and nutrition disorders | Frequent | Anorexia hypercholesterolemia |
Nervous system disorders | Very common | headaches |
Frequent | Drowsiness Carpal tunnel syndrome* | |
Vascular disorders | Very common | Hot flashes |
Gastrointestinal disorders | Very common | nausea |
Frequent | diarrhea vomiting | |
Hepatobiliary disorders | Frequent | Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase |
Rare | Increases in gamma-GT and bilirubin levels Hepatitis | |
Skin and subcutaneous tissue disorders | Very common | Skin rash |
Frequent | Hair resorption (alopecia) Allergic reactions | |
Rare | Urticaria | |
Rare | Erythema multiforme Anaphylactoid reaction Cutaneous vasculitis (including some cases of Henoch-Schönlein purpura) ** | |
Very rare | Stevens-Johnson Syndrome Angioedema | |
Musculoskeletal and connective tissue disorders | Very common | Arthralgia / joint stiffness Arthritis osteoporosis |
Frequent | Bone pain | |
Rare | Spring finger | |
Disorders of reproductive organs and breast | Frequent | Vaginal dryness Vaginal bleeding *** |
General disorders and administration site conditions | Very common | Asthenia |
* Carpal tunnel syndrome events have been reported in greater numbers in patients treated with anastrozole in clinical trials than among those receiving tamoxifen therapy. However, the majority of these events occurred in patients with identifiable risk factors for the onset of these events.
** Since no case of cutaneous vasculitis or Henoch-Schönlein purpura was observed in the ATAC study, the frequency of these events can be considered as "rare" (≥ 0.01% and <0.1 %) on the basis of the least favorable estimate.
*** Vaginal bleeding has been reported frequently, mainly in patients with advanced breast cancer, during the first few weeks after the relapse of existing anastrozole hormone therapy. If bleeding persists, further exploration should be considered.
The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, regardless of treatment causality, observed in patients receiving study treatment and up to 14 months of age. days after stopping treatment of the study.
Table 2. Pre-specified adverse events in the ATAC study
Side effects | Anastrozole (N = 3092) | Tamoxifen (N = 3094) |
Hot flashes | 1, 104 (35.7%) | 1, 264 (40.9%) |
Pain / joint stiffness | 1, 100 (35.6%) | 911 (29.4%) |
Mood disorder | 597 (19.3%) | 554 (17.9%) |
Fatigue / asthenia | 575 (18.6%) | 544 (17.6%) |
Nausea and vomiting | 393 (12.7%) | 384 (12.4%) |
fractures | 315 (10.2%) | 209 (6.8%) |
Fractures of the spine, hip or wrist (Pouteau-Glues) | 133 (4.3%) | 91 (2.9%) |
Wrist Fractures / Pouteau-Adhesives | 67 (2.2%) | 50 (1.6%) |
Fractures of the spine | 43 (1.4%) | 22 (0.7%) |
Hip fractures | 28 (0.9%) | 26 (0.8%) |
cataracts | 182 (5.9%) | 213 (6.9%) |
Vaginal bleeding | 167 (5.4%) | 317 (10.2%) |
Ischemic cardiovascular disease | 127 (4.1%) | 104 (3.4%) |
Angina pectoris | 71 (2.3%) | 51 (1.6%) |
Myocardial infarction | 37 (1.2%) | 34 (1.1%) |
Coronary artery disease | 25 (0.8%) | 23 (0.7%) |
Myocardial ischemia | 22 (0.7%) | 14 (0.5%) |
Vaginal discharge | 109 (3.5%) | 408 (13.2%) |
Any venous thromboembolic event | 87 (2.8%) | 140 (4.5%) |
Deep venous thromboembolic event, including pulmonary embolism | 48 (1.6%) | 74 (2.4%) |
Ischemic cerebrovascular events | 62 (2.0%) | 88 (2.8%) |
Endometrial cancer | 4 (0.2%) | 13 (0.6%) |
After a median follow-up of 68 months, the observed fracture rates were 22 per 1, 000 patient-years and 15 per 1, 000 patient-years in the anastrozole and tamoxifen groups, respectively. The fracture rate observed with anastrozole is similar to that reported in postmenopausal women of similar ages. The incidence of osteoporosis was 10.5% in patients treated with anastrozole and 7.3% in patients treated with tamoxifen.
It could not be established whether the fracture and osteoporosis rates observed in the ATAC study in patients on anastrozole reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.
